Emotional Assessment and Tiered Individualized Psychological Support for Newly Diagnosed Postoperative Gynecologic Patients: Development and Testing of the E-MOTE Artificial Intelligence Robot
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Distress
研究概览
简要总结
To develop the E-MOTE robot and evaluate its effectiveness in addressing psychological distress, physical symptom, stress index, and quality of life, as well as to explore its clinical applicability.
详细描述
This study is grounded in the Social Cognitive Theory of Self-Regulation as its theoretical framework and aims to develop a robot equipped with functions of Emotion, Monitor, Optimize, Tailor, and Engage (E-MOTE). The intervention is designed to support newly diagnosed gynecological cancer patients in more effectively managing their emotions throughout the surgical treatment process, with the goal of positively influencing symptom management and quality of life.At the same time, the investigators will conduct qualitative interviews with nursing staff to understand their perceptions and thoughts about the robot.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stage 1 (For patients and nurse) ***Patients***
- •Inclusion Criteria:
- •Aged 18 years or older.
- •Diagnosed with gynecologic cancer and undergoing surgery.
- •Willing to receive E-MOTE robot and wear a smart wearable device.
- •Willing to complete pre-test and post-test questionnaires.
排除标准
- •Unable to communicate clearly.
- •Unwilling or unable to participate in the study in its entirety.
- •***Nurse***
- •Inclusion Criteria:
- •Aged 18 years or older.
- •As a clinical nurse and has cared for patients who received the E-MOTE robot
- •Exclusion Criteria:
- •- Unwilling to participate in the qualitative interview.
- •Stage 2 (only for patients) ***Intervention group***
- •Inclusion Criteria:
- •Aged 18 years or older.
- •Diagnosed with gynecologic cancer and scheduled to undergo surgery.
- •Willing to receiveE-MOTE robot and to wear a smart wearable device.
- •Willing to complete pre-test and post-test questionnaires.
- •Exclusion Criteria:
- •Unable to communicate clearly.
- •Unwilling or unable to participate in the study in its entirety.
- •***Control group***
- •Inclusion Criteria:
- •Aged 18 years or older.
- •Diagnosed with gynecologic cancer and scheduled to undergo surgery.
- •Willing to complete pre-test and post-test questionnaires.
- •Exclusion Criteria:
- •Unable to communicate clearly.
- •Unwilling or unable to participate in the study in its entirety.
研究组 & 干预措施
Control Group
Routine care
Intervention Group
The intervention group will receive the E-MOTE robot, which conducts emotional assessments, and provides a session of self-affirmation relaxation training followed by a Q&A session.
干预措施: E-MOTE group (Other)
结局指标
主要结局
Distress
时间窗: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.
Investigators utilized the Distress Thermometer(DT) as the primary outcome measure. The scale uses a 11 Liker scale, where 0 indicates no distress at all and 10 represents the most severe distress.Higher score indicates a more severe distress. When the score is 4 or higher, a Problem List (PL) is used to further identify factors contributing to the emotional distress.
Depression
时间窗: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.
Investigators utilized the Patient Health Questionnaire (PHQ-9) as the primary outcome measure to assess depression. The scale consists of 9 items, each rated on a 4-point Likert scale (0 = not at all, 3 = nearly every day). The total score ranges from 0 to 27, and depression severity can be categorized as mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20 or above).Higher score indicates a more severe depression.
次要结局
- Usability of the robot(Measurements will be taken three days post-surgery.)
- Quality of Life Measurement(Measurements will be taken before the intervention, three days after surgery, and one week after discharge.)
- Loneliness(Measurements will be taken before the intervention, three days after surgery, and one week after discharge.)
- Symptom Severity(Measurements will be taken before the intervention, three days after surgery, and one week after discharge.)
- Physiological objective indicators(Measurements will be taken before the intervention, three days after surgery, and one week after discharge.)